1. Field of the invention
The invention relates to the field of treatment for male and female reproductive varices, in particular for varicoceles in men and pelvic varices in women, and includes oesophageal varices.
2. Information Disclosure Statement
Varices are uneven, permanent dilations of veins than can occur in numerous areas of the body, and are very common in the superficial veins of the lower limbs (varicose, spider veins). One manifestation of these varices that occurs in men, and is the most common cause of male infertility, is the varicocele. Between 10 and 20% of post-pubescent males are affected by varicoceles, and 20-40% of all infertile males have varicoceles. A varicocele specifically refers to dilatation and tortuosity of the pampiniform plexus. Pampiniform plexus is the network of veins that drain the testicle. Plexus travels along the posterior part of the testicle with the epididymis and vas deferens, and then into the spermatic cord, which extends from the testes up through the ingiunal canal in the lower abdominal wall to the circulatory system. The vas deferens is not situated by itself but is a part of a larger tissue bundle called the spermatic cord. The spermatic cord contains many blood vessels as well as the vas deferens, nerves, and lymphatic channels. Hence care needs to be taken to avoid vas deferens and vessels to avoided permanent damage to testis.
A varicocele can develop in one or both testicles, but in most cases occurs in the left testicle. Because of the varicocele's impairment of blood flow, the blood cannot cool as it does in normal veins, and this increased temperature is thought to be a cause of infertility. The excess heat can damage sperm or impede the production of new healthy sperm.
Varices can also play a role in chronic pelvic pain syndrome in women. One of numerous causes of chronic pelvic pain in women is “pelvic congestion syndrome” (PCS), a condition in which varices form in the pelvis minor, affecting organs including the uterus, ovaries and vulva. PCS is analogous to varicoceles in men. Pelvic varices occur in around 10% of the female population, and varices occur usually in women of the ages of 20-50.
A variety of treatments have been attempted for female pelvic varices, with varying degrees of success. Medications, including vasoconstrictors and hormonal medications, have been used successfully, though they may not always provide long-term relief. Numerous surgical treatments have also been performed, including tying off or removing veins, uterine suspension, and, generally as a last resort, hysterectomy.
Numerous options are also available for treatment of male varicoceles. Surgical treatment, usually performed under general anesthetic, involves making an incision above the scrotum and tying off the veins to detour blood flow into normal veins. Such a procedure can require up to six weeks recovery time before heavy lifting can be performed, with light activities able to be performed earlier.
Embolization is a procedure used by surgeons to block fluid flow through a blood vessel or organ, and has been used to treat both male varicoceles and female pelvic varices with at least some success. An embolus, which is a mass of some material, is inserted into the blood vessel with a catheter and is lodged in the vessel to restrict blood or fluid flow. This causes a clot to develop in the vessel that closes off the vessel. Types of emboli include wire coils, sponges, “chemical cross-linking means such as cyanoacrylate”, balloons, umbrella-like devices and other types of plugs. (U.S. Pat. No. 5,167,624)
U.S. Pat. No. 4,509,504 discloses the use of a device consisting of a material that swells when in contact with body fluid. The device is inserted into a body passage and the material is swelled to occlude the passage. The passages could be blood vessels (including varicose veins), urethers, spermatic ducts and oviducts. The device can purportedly be used as a contraceptive. When swelled, the device anchors in position and fully occludes the passage.
U.S. Pat. No. 6,200,332 describes a device and method for underskin laser treatment. Indications such as wrinkles and varicose veins can be treated with this invention. The handpiece uses a standard needle to insert an optical fiber under the skin or into a blood vessel, and features an extension piece that maintains the end of the optical fiber in a fixed position relative to the handpiece. The method described in this invention is generally envisioned for the treatment of tissue near the surface of the skin, for cosmetic procedures such as surface varicose veins or wrinkle removal. It is not suitable for deep interior treatments such as varicoceles or pelvic varices because of the anatomical positions and function. Again because of the anatomical position of the vein care needs to be taken to avoid damages to renal arterial, like transection, intimal tears, or thrombotic occlusion
U.S. Pat. No. 5,167,624 describes a method and apparatus for passing an embolus into a blood vessel. The embolus lodges in the vessel and allows formation of a vessel-occluding clot around the embolus. The embolus is hydraulically passed through the lumen of a catheter to a given point in a blood vessel; the hydraulic fluid pushed the embolus to a predetermined position in the blood vessel. The embolus is preferably a coil that is stretched in the catheter lumen and recoils once released into the blood vessels. The recoiling causes the spring to expand and exert a force on the wall of the blood vessel to anchor it in place.
U.S. Application No. 2002/0156499 describes an apparatus and method featuring a deformable member for occluding a blood vessel. Upon application of force on the occluder, the occluder can be deformed to expand to fully occlude a vessel, and may further be anchored so that migration can be avoided.
WO 01/66016 A1 describes embolic particles, agents and compositions, visible by ultrasound, for embolization to treat various disorders such as varicocele. Microbubbles are incorporated into or around the particles to allow the particles or composition to visible by ultrasound, thus avoiding the need for fluoroscopy and contrast agents in angiography.
Embolization procedures are typically outpatient procedures that require 24 hours or less of recovery time. Disadvantages include the relative complexity of the inserted embolus and the associated delivery equipment and the increased risk of infection, migration, or other complications due to the need to deposit and secure a foreign body within the blood vessel.
WO2009109967A1 discloses a method for collapsing a target vein comprising providing an intravascular irritation element having mechanical irritating objects, inserting the intravascular irritation element into a venous lumen of a target vein, and irritating the target vein by moving mechanical irritating objects in contact with the inner surface triggering a collapse of said target vein. Irritating objects include a shape memory element having a regainable geometry, wherein the providing comprises providing the intravascular irritation element in a collapsed state and the irritating comprises allowing the shape memory element to expand toward the regainable geometry in the venous lumen. Optionally, the irritating comprises rotating the intravascular irritation element around a longitudinal axis of the target lumen or brushing irritation element against the inner surface in a helical pattern. Inserting comprises releasing a sclerosing agent in proximity to the inner surface or withdrawing blood in proximity to the inner surface. Causing vein collapse by mechanical irritation lacks effectiveness and is often only a temporary benefit.
Most of the procedures discussed in the prior art use invasive methods. Since varicoceles in men and pelvic varices in women are known to involve the reproductive organs extra care needs to be taken since most patients affected are in reproductive age group. The Pampiniform plexus in the testis and pelvis minor in pelvic regions, which are affected by varices are connected to other major veins, which are again connected to other vital organs in the abdominal cavity, and are surrounded by other major arteries and nerves in the regions, hence utmost care needs to be taken while accessing this vein unlike the veins in the legs. Any damage to the other veins or artery can cause significant, irreversible damage to reproductive organs.
In prior art cases the vein closure is not complete because collateral veins running parallel to testicular vein are missed, and recurrence is common. Collateral veins are difficult to identify and ligate separately from the testicular artery. Similarly access to the right internal spermatic vein is very difficult and requires significant time.
Other disadvantages include long duration of the procedure, Seduction, failure to access the internal spermatic vein, radiation exposure and recurrent varicocele. And most importantly the success of these procedures is clearly dependent upon a high level of skill and experience of the interventional radiologist.
There remains a need for a minimally invasive treatment of varicocele and other delicately placed abnormal veins that does not require the permanent or extended insertion of foreign objects and can be performed with a minimum of pain and without significant recovery time. The present invention addresses these needs.